Significant changes in blood sugar control in patients with uncontrolled type 2 diabetes

LONDON, UK AND WALTHAM, MA. – September 28, 2015 – Fractyl Laboratories, Inc. (Fractyl) today announced results from a 39-patient, single-site, proof-of-concept study demonstrating that a minimally invasive procedure using the Revita™ Duodenal Mucosal Resurfacing™ (DMR) System produces significant, beneficial changes in blood sugar in patients with poorly controlled type 2 diabetes, similar to results seen with more invasive bariatric surgery procedures. Alan D. Cherrington, PhD, Professor of Medicine and Molecular Physiology and Biophysics at Vanderbilt University, presented the data during the 3rd World Congress on Interventional Therapies for Type 2 Diabetes and 2nd Diabetes Surgery Summit in London, UK (www.wcitt2d.org). A multicenter clinical trial of Revita DMR (“Revita-1” trial) is currently underway in Europe and South America.

“I appreciate having the opportunity to present our data. Patients in this study had poorly controlled type 2 diabetes, despite medication use. They experienced a significant improvement in HbA1c after this minimally invasive procedure, as well as some weight loss,” said Dr. Cherrington. “With this study, we continue to see evidence that the biology of the intestine plays a very important role in type 2 diabetes pathology, and that altering it can meaningfully improve blood sugar control.”

In the proof-of-concept study, 39 patients with poorly controlled type 2 diabetes (HbA1c > 7.5% on at least 1 oral anti-diabetic agent) received DMR on a long-segment (> 9 cm; LS-DMR; n=28) or a short segment (< 6 cm; SS-DMR; n=11) of the duodenum. The primary endpoints were safety and reduction in HbA1c, assessed over a follow-up period of 6 months. Baseline mean HbA1c (9.5 percent) was reduced more by LS-DMR than SS-DMR at 3 months post-procedure, suggesting a dose-dependent treatment effect from DMR (p<0.05 for LS vs SS). In LS-DMR patients with baseline HbA1c of 7.5 to 10 percent and stable concomitant anti-diabetic medications, HbA1c after LS-DMR decreased from 8.5 percent to 7.1 percent (p<0.05) at 6 months, accompanied by a modest weight reduction of 2.3 kg. There was no apparent correlation between degree of weight loss and magnitude of HbA1c improvement. Three patients experienced duodenal stenosis that required endoscopic balloon dilation, all with good resolution.

“Earlier this month, our team published a five-year follow-up study showing that surgery may be more effective than standard medical treatments for the long-term control of type 2 diabetes in obese patients,” said Francesco Rubino, MD, Chair of Bariatric Surgery at King’s College London and Consultant Surgeon at King’s College Hospital in London, UK. “This is a huge shift in how we think about the disease. It will be exciting to see if these early results using a much less invasive duodenal mucosal resurfacing approach will be reproduced in larger studies.”

In July 2015, Fractyl announced the start of the Revita-1 study, which will enroll 50 patients across ten international sites in its first phase. The primary efficacy endpoint is change in HbA1c in patients with uncontrolled type 2 diabetes, defined as having poor glucose control on oral medications and an HbA1c of 7.5 to 10 percent. To date, 20 patients have been treated in the Revita-1 study. The second phase of the study, a double-blinded, sham-controlled trial that will enroll up to 240 patients, will begin in 2016.

“These results are helpful as we design our path to market, including pivotal trials in Europe and the United States,” said Harith Rajagopalan, MD, PhD, Co-Founder and CEO of Fractyl. “It is exciting to have our data presented at WCITT2D in context of the spectrum of novel intervention therapies for type 2 diabetes.”

About Fractyl and the Revita™ Duodenal Mucosal Resurfacing (DMR) System

Fractyl Laboratories, Inc., a private company based in Waltham, MA, was founded with the mission to change the treatment of type 2 diabetes. Fractyl has developed a minimally invasive, device-based, implant-free duodenal mucosal resurfacing procedure (Revita DMR) that directly addresses the intestinal hormonal impairment that contributes to insulin resistance and changes how the body absorbs and processes sugar. Fractyl is currently engaged in clinical trials designed to demonstrate that the Revita DMR procedure can dramatically improve glucose control and potentially reduce the need for additional medications in type 2 diabetes. For more information, visit www.fractyl.com, http://www.twitter.com/FractylLabs or http://revitatrial.com.